Fair Warnings for All Drugs

The U.S. Food and Drug Administration (the FDA) is finally initiating a
long-needed change to its regulations which would place the same safety
protections on generic drugs as currently exist for their brand-name counterparts.
For many years the FDA has required the pharmaceutical industry to add
label warnings and precautions as soon as the drug manufacturers became
aware of new risks or side effects. This information is so important to
consumers that medical proof establishing that the drug caused the side-effect
isn’t even necessary to initiate a labeling change.Also, FDA approval
of these new or expanded warnings is not required before taking action
to add the new warnings.

However, in June 2011, the U.S. Supreme Court held in a case called Mensing
v. Pliva that the manufacturers of generic drugs could not be held accountable
to patients for failing to similarly update their drug labels.

Given the fact that approximately 80% of patients take generic versions
of prescription drugs, some members of Congress, members of the medical
community, and consumer groups have been urging the FDA to correct this
inconsistent treatment created by the Mensing decision. On November 13,
2013, the FDA submitted a proposed change to its drug labeling regulations
which would, if adopted, permit generic drug manufacturers to initiate
labeling changes (regardless of the labeling on their brand-name equivalents)
to warn prescribing doctors and patients of new drug safety risks.

Permitting generic drug manufacturers to include these important side-effect
warnings is very important to ensure the safety of those who take generic
medications. The FDA will be accepting comments from the public regarding
this proposed regulatory change for a period of 60 days. Hopefully, the
regulation will become effective after the comment period is over. Those
who wish to submit a comment may do so at:
www.regulations.gov.